Strong transparency programs and systems are home base to successful compliance programs. Consider ways to strengthen and support ethics and compliance through transparency reporting.
- Visualize and build successful transparency reporting frameworks as a strong foundation for compliance programs
- Recognize the importance of transparency data to inform the organization
- Consider ways to grow your role in transparency and compliance career
Transparency program costs and operating model considerations for a scalable and flexible future
Many pharma and life sciences companies are struggling with outsized expenses and needless complexity when it comes to regulatory compliance. Some companies are realizing that rushed solutions of the past may have met regulatory deadlines, but may not be efficiently or effectively addressing their business and compliance requirements. To address these challenges, coverage will include:
- Cost considerations to enable a complete evaluation of your current transparency program
- What to evaluate when considering existing and future technology
- Opportunities to manage data across legacy and disparate systems, including multiple regions and locations throughout the globe
March 2022 was the first Open Payments deadline which required expanded reporting to include five additional provider types: physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists and anesthesiologist assistants, and certified nurse-midwives. What are the most important lessons learned for reporting expanded provider data?
- Identify tips for streamlining the data collection and reporting of an expanded list of covered recipients and nature of payment categories
- Understand potential solutions for problems with matching expanded provider data, validation rules and data revisions
- Pinpoint opportunities for improving efficiency of internal processes including what to look for in new CMS data being published summer 2022
- Discuss device IDs and challenges in selecting appropriate approaches
Compliance monitoring of transparency data often flags important indications. Assess a process for reviewing frequencies and related implications.
- Examine overall frequency of HCP payment
- Review frequency with regard to recent changes in PhRMA code regarding speaker programs changes
- Grasp the implications for compliance monitoring resulting from identification of frequencies in speaking engagements
- Review frequency of HCP payments in virtual world
Benefit from best practices in compliance monitoring, auditing and data analytics.
- Strengthen compliance programs through data analytics
- Considerations for data collection
- Identify gaps in internal processes for auditing and monitoring
- Key Risk Indicators
- Global data analytics considerations
There are many steps to consider when working with data and safeguarding data integrity. Hear about an approach to data cleaning, analytics, and application.
- Implement a process for data scrubbing and scrutiny
- Review data in as close to real-time as possible to safeguard data integrity
- Communicate analysis and summary of Open Payments published data to internal teams and functions to share knowledge
If you have experience with Open Payments reporting you may know what to look for to identify gaps and make improvements for reporting next January. It is critical to document and share knowledge for how to standardize reporting processes and systems for optimum efficiency.
- Obtain ideas for how to review your previous year report to spot gaps and opportunities for improvement
- Determine where and when to make changes that make a difference
- Communicate summary of findings to stakeholders in need of making changes
One of the most successful ways to steer the effectiveness and increase the value of your transparency team is to implement guiding principles. Find out more about how to lead teams and stay nimble in an ever changing environment.
- Create liaisons with business unit partners and collaborate to help them meet their goals compliantly
- Use short trainings and business scenario one pagers to communicate the implications of regulations on day-to-day operations
- Investigate root causes when they arise and keep documentation of all issues
Gain an overview of enforcement actions involving implications for compliance with Physician Payments Sunshine Act.
- Discuss DOJ enforcement initiatives regarding intertwined Physician Payments Sunshine Act, the False Claims Act and Anti-Kickback Statute
- Recognize how OIG, DOJ, CMS and the Plaintiffs’ Bar look at Open Payments data?
- What haven’t we seen yet when it comes to enforcement and where is the future headed?
Examine emerging country and regional transparency regulations including the EFPIA disclosure code.
- Steps to ensure consistency in global data capture and reporting
- Identify best methods for streamlining processes for global spend reporting
- How to best leverage systems already in place
Develop and implement a strategic vision for meeting global transparency requirements.
- Gain insight and ideas for structuring your program
- Determine your approach for identifying and managing country specific regulations and codes
- Understand the impact of cross border HCP payments
- Partner with other functions to improve data quality and meet requirements beyond transparency (e.g., GDPR)
Global transparency compliance requires an efficient system for staying current on evolving regulations and codes. Glean best practices for operationalizing compliance with global transparency reporting.
- Develop a system for managing documentation, timelines and deadlines for global reporting
- Engage cross-functional and global spend transparency champions throughout your organization worldwide
- Analyze the differences in the approach to transparency reporting globally and glean tips on changing requirements in France, New Zealand and more
Preparing and reviewing aggregate spend data and managing data remediation efforts for state reporting is not an easy task. Hear updates and changes to state regulations relevant to transparency reporting and pharma rep licensing and reporting requirements.
- Hear an enforcement update on state level enforcement trends and future priorities
- Learn about updates and changes in regulation state to state expanded covered entities and nature of payment categories
- Get an update on requirements related to pharma rep licensing and reporting
Examine how to report payments when a drug manufacturer buys a share of ownership in a company that is at least partially owned by a physician or a physician’s immediate family member.
- Pinpoint how to identify physician owned entities
- Understand implications of M&A involving venture capital
- Identify what is included or not included regarding indirect transfers of value
Demonstrate the added value of your analytics pre and post-reporting to your internal stakeholders.
- Use data analytics for informed decisions regarding efficiency and effectiveness of the transparency program
- Identify trends and frequency patterns
- Use data analytics to target compliance audits & monitoring